Lasmiditan

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Reyvow
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Lasmiditan
Clinical data
Pronunciation/læzˈmɪdɪtæn/
laz-MID-i-tan
Trade namesReyvow, Rayvow
Other namesCOL-144
AHFS/Drugs.comMonograph
MedlinePlusa620015
License data
intravenous
ATC code
Legal status
Legal status
Identifiers
  • 2,4,6-Trifluoro-N-[6-[(1-methyl-4-piperidinyl)carbonyl]-2-pyridinyl]benzamide
JSmol)
  • CN1CCC(CC1)C(=O)C2=NC(=CC=C2)NC(=O)C3=C(C=C(C=C3F)F)F
  • InChI=1S/C19H18F3N3O2/c1-25-7-5-11(6-8-25)18(26)15-3-2-4-16(23-15)24-19(27)17-13(21)9-12(20)10-14(17)22/h2-4,9-11H,5-8H2,1H3,(H,23,24,27) ☒N
  • Key:XEDHVZKDSYZQBF-UHFFFAOYSA-N ☒N
 ☒NcheckY (what is this?)  (verify)

Lasmiditan, sold under the brand name Reyvow, is a medication used for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults.[1] It is not useful for prevention.[1] It is taken by mouth.[1]

Common side effects include sleepiness, dizziness, tiredness, and numbness.[4][5]

Lasmiditan was approved in the United States in October 2019[4] and became available in February 2020.[6] It was developed by Eli Lilly.[4] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7]

Pharmacology

Mechanism of action

Lasmiditan is a

Raynaud's phenomenon or after a myocardial infarction,[8] although a 1998 review has found such side-effects to rarely occur in people taking triptans.[9][10]

Adverse effects

There is a risk of driving impairment while taking lasmiditan. People are advised not to drive or operate machinery for at least eight hours after taking lasmiditan, even if they feel well enough to do so. People who cannot follow this advice are advised not to take lasmiditan. The drug causes central nervous system (CNS) depression, including dizziness and sedation. It should be used with caution if taken in combination with alcohol or other CNS depressants.[1]

History

Lasmiditan was discovered by Eli Lilly and Company and was then relicensed to CoLucid Pharmaceuticals in 2006, until CoLucid was bought by Eli Lilly in 2017, to allow Eli Lilly to reacquire the drug's intellectual property.[11] The drug is protected by patents until 2031.[12]

Phase II clinical trials for dose finding purposes were completed in 2007, for an intravenous form

new drug application to the U.S. Food and Drug Administration (FDA) in November 2018.[15]

Three phase III clinical trials were completed. The SPARTAN trial compared placebo with 50, 100, and 200 mg of lasmiditan.

open-label study that compared 100 and 200 mg doses of lasmiditan in subjects that received the drug as part of a prior trial.[17]

Topline results from the SPARTAN trial showed that the drug induced met its primary and secondary endpoints in the trial. The primary result showed a statistically significant improvement in pain relief relative to placebo 2 hours after the first dose. The secondary result showed a statistically significantly greater percentage of subjects were free of their most bothersome symptom (MBS) compared with placebo at two hours following the first dose.[18]

The FDA approved lasmiditan primarily based on data from two clinical trials, Trial 1 (# NCT02439320) and Trial 2 (#NCT02605174) of 4439 subjects with migraine headaches with or without aura.[19] Trials were conducted at 224 sites in the United States, the United Kingdom, and Germany.[19]

The FDA approved the drug in October 2019.[19] It was placed into Schedule V in January 2020.[2][20]

Society and culture

Legal status

On 23 June 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Rayvow, intended for the treatment of migraine.[21] The applicant for this medicinal product is Eli Lilly Nederland B.V.[21] Rayvow was approved for medical use in the European Union in August 2022.[3][22]

Lasmiditan has not been approved for use in Canada. The drug sponsor in Canada, Eli Lilly Canada Inc., filed a New Drug Submission in February 2020 but cancelled the submission before a final decision was issued by Health Canada. Health Canada had completed their review of the submission and did not find any deficiencies in the data packages provided in the submission. However, Health Canada and Eli Lilly could not come to agreement on the interpretation of the cardiovascular data and how it would be worded in the product monograph. The drug sponsor cancelled their submission on 26 January 2021 before Health Canada issued a final decision.[23]

References

  1. ^ a b c d e "Reyvow- lasmiditan tablet". DailyMed. 11 October 2019. Archived from the original on 25 November 2020. Retrieved 15 November 2019.
  2. ^ a b "2020 - Placement of Lasmiditan in Schedule V". DEA Diversion Control Division. 31 January 2020. Archived from the original on 31 January 2020. Retrieved 31 January 2020.
  3. ^ a b "Rayvow EPAR". European Medicines Agency (EMA). 14 September 2021. Archived from the original on 6 October 2022. Retrieved 6 October 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  4. ^ a b c "FDA approves new treatment for patients with migraine". U.S. Food and Drug Administration (FDA) (Press release). 11 October 2019. Archived from the original on 16 November 2019. Retrieved 17 October 2019. Public Domain This article incorporates text from this source, which is in the public domain.
  5. ^ "Lasmiditan (Professional Patient Advice)". Drugs.com. 4 June 2019. Archived from the original on 27 January 2020. Retrieved 23 February 2020.
  6. ^ "Lilly's Reyvow (lasmiditan) C-V, the First and Only Medicine in a New Class of Acute Treatment for Migraine (ditan), Now Available for Prescription". Eli Lilly and Company (Press release). 31 January 2020. Archived from the original on 23 February 2020. Retrieved 23 February 2020.
  7. ^ "New Drug Therapy Approvals 2019". U.S. Food and Drug Administration. 31 December 2019. Archived from the original on 16 September 2020. Retrieved 15 September 2020.
  8. ^ "Molecule of the Month July 2010: Lasmiditan hydrochloride". Prous Science. Archived from the original on 28 July 2011. Retrieved 3 August 2011.
  9. S2CID 30125923
    .
  10. OCLC 47700647
    .
  11. ^ "Lilly buys migraine biotech CoLucid, and the drug it outlicensed, for $960M". 18 January 2017. Archived from the original on 25 September 2020. Retrieved 30 January 2017.
  12. ^ "Lasmiditan - Eli Lilly and Company - AdisInsight". Archived from the original on 26 September 2021. Retrieved 30 January 2017.
  13. ^ "A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine". ClinicalTrials.gov. 8 November 2019. Archived from the original on 23 February 2020. Retrieved 23 February 2020.
  14. ^ "Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment". ClinicalTrials.gov. 20 December 2019. Archived from the original on 23 February 2020. Retrieved 23 February 2020.
  15. ^ "Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine, Receives Breakthrough Therapy Designation for Emgality (galcanezumab-gnlm) for Prevention of Episodic Cluster Headache" (Press release). Eli Lilly and Company. 14 November 2018. Archived from the original on 12 October 2019. Retrieved 12 October 2019 – via PR Newswire.
  16. ^ Clinical trial number NCT02605174 for "Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine (SPARTAN)" at ClinicalTrials.gov
  17. ^ Clinical trial number NCT02565186 for "An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine (GLADIATOR)" at ClinicalTrials.gov
  18. ^ "Lilly Announces Positive Results for Second Phase 3 Study of Lasmiditan for the Acute Treatment of Migraine". Archived from the original on 5 August 2017. Retrieved 5 August 2017.
  19. ^ a b c "Drug Trials Snapshots: Reyvow". U.S. Food and Drug Administration (FDA). 11 October 2019. Archived from the original on 13 December 2019. Retrieved 26 January 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  20. ^ "Schedules of Controlled Substances: Placement of Lasmiditan in Schedule V". Federal Register. 31 January 2020. Archived from the original on 26 March 2021. Retrieved 31 January 2020.
  21. ^ a b "Rayvow: Pending EC decision". European Medicines Agency (EMA). 23 June 2022. Archived from the original on 26 June 2022. Retrieved 26 June 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  22. ^ "Rayvow Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  23. ^ "Regulatory Decision Summary - Reyvow". Health Canada. 23 October 2014. Retrieved 22 June 2023.
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